GSK wins EU approval for Shingrix prefilled syringe format
GSK plc reports that the European Commission has approved a new prefilled syringe presentation of Shingrix, its Recombinant Zoster Vaccine for shingles.
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GSK plc reports that the European Commission has approved a new prefilled syringe presentation of Shingrix, its Recombinant Zoster Vaccine for shingles. The current version requires healthcare professionals to reconstitute a lyophilised antigen with a liquid adjuvant from two separate vials. The new format comes as a prefilled syringe, removing the reconstitution step and making administration simpler and more convenient in clinical settings.
The approval is based on data showing technical comparability between the prefilled syringe and the existing presentation, with no changes to the vaccine’s indication or dosing. Shingrix continues to be authorised in the European Union to prevent herpes zoster and post‑herpetic neuralgia in adults from age 50, and from age 18 for those at increased risk. GSK plans to begin rolling out the prefilled syringe across EU countries in 2026, aiming to support broader and easier protection against shingles, which affects around 1.7 million people in Europe each year.
FAQ
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What did GSK (GSK) announce about Shingrix in Europe?
GSK announced that the European Commission has approved a new prefilled syringe presentation of Shingrix, its Recombinant Zoster Vaccine for shingles, providing a more convenient administration option for healthcare professionals.
How does the new Shingrix prefilled syringe differ from the existing presentation?
The existing Shingrix presentation uses two vials, with a lyophilised powder antigen that must be reconstituted using a liquid adjuvant. The new presentation comes as a single prefilled syringe, eliminating the reconstitution step before administration.
Does the new Shingrix presentation change the vaccine’s indication or dosing?
No. GSK states that the new prefilled syringe presentation is based on data confirming technical comparability with the existing version and that it does not involve any change in indication or dosing.
When will GSK’s Shingrix prefilled syringe roll out across EU countries?
GSK indicates that the new Shingrix prefilled syringe presentation will begin rolling out across European Union countries in 2026, following the European Commission’s approval.
Who is currently indicated to receive Shingrix in the European Union?
Shingrix has been approved in the European Union for the prevention of herpes zoster (shingles) and post‑herpetic neuralgia in adults aged 50 years or older since 2018, and in adults 18 years or older at increased risk of shingles since 2020.
Why is simplifying Shingrix administration important according to GSK?
GSK highlights that shingles is a painful disease with potential long‑lasting complications and that it affects approximately 1.7 million people in Europe each year. The company notes that an easier‑to‑use prefilled syringe can help healthcare professionals provide protection more efficiently.
What is shingles and who is at higher risk, as described by GSK?
Shingles is caused by reactivation of the varicella‑zoster virus, which lies dormant after chickenpox. GSK notes that up to 1 in 3 adults may develop shingles in their lifetime, and that advancing age and chronic conditions such as cardiovascular disease, chronic kidney disease, COPD, asthma, and diabetes are linked to higher risk.
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